Regulators Approve Wireless Neurological Implants For Treatment Resistant Depression #
Houston — The U.S. Food and Drug Administration has authorized human trials for a wirelessly powered brain implant designed to monetize neurological health. Motif Neurotech secured an Investigational Device Exemption for its RESONATE study, allowing the commercial deployment of the Motif XCS System. The hardware delivers targeted electrical stimulation to alleviate severe depression.
The authorization opens a highly lucrative frontier in the metabolic and cognitive divide. "The patients who will participate in RESONATE have exhausted existing treatment options and are putting their trust in us, and IDE approval from the FDA is confirmation of the care and rigor our team has put into our therapy," said Motif Chief Operating Officer Nick Halper.
Simultaneously, Berlin Heals reported positive data from its First-In-Human CMIC-III study in Chicago. The trial demonstrated that cardiac microcurrent devices can be implanted via outpatient procedures. "These new data from the CMIC-III study show that we can achieve comparable improvements using a less invasive, outpatient procedure, significantly enhancing the safety profile and expanding access to a much broader population of patients," said Professor William T.